Soft Tissue Repair Device And Associated Method

ABSTRACT

A soft tissue repair device can include a housing having a handle, a deployment system having an actuation member, and an insertion system having an inserter and a slider. The slider can be coupled to the actuation member and movable relative to the inserter between deployed and retracted positions. First and second anchors can be carried on an external surface of the slider such that the anchors are spaced apart and portions of the anchors are coaxial with the slider and each other. A flexible strand can couple the anchors. The insertion system can cooperate with the deployment system to move the slider to the deployed position to deploy the first anchor upon activating the actuation member a first time, and to move the slider to the deployed position from the retracted position to deploy the second anchor upon actuating the actuation member a second time after the first time.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.12/570,854 filed Sep. 30, 2009, which is a continuation-in-partapplication of U.S. patent application Ser. No. 12/489,181 filed Jun.22, 2009, which is a continuation-in-part application of U.S. patentapplication Ser. No. 12/474,802 filed on May 29, 2009, now U.S. Pat. No.8,088,130 issued on Jan. 3, 2012, which is a continuation-in-partapplication of: (1.) U.S. patent application Ser. No. 11/541,506 filedon Sep. 29, 2006, now U.S. Pat. No. 7,601,165 issued on Oct. 13, 2009,and (2.) U.S. patent application Ser. No. 11/541,505 filed on Sep. 29,2006, now U.S. Pat. No. 7,658,751 issued on Feb. 9, 2010.

This application is a divisional of U.S. patent application Ser. No.13/045,691 filed on Mar. 11, 2011, which is a continuation-in-partapplication of U.S. patent application Ser. No. 12/014,399 filed on Jan.15, 2008, now U.S. Pat. No. 7,909,851 issued on Mar. 22, 2011, whichclaims the benefit of: (1.) U.S. Provisional Application No. 60/885062,filed on Jan. 16, 2007, and (2.) U.S. Provisional Application No.60/885057, filed on Jan. 16, 2007.

This application is a divisional of U.S. patent application Ser. No.13/045,689 filed on Mar. 11, 2011, which is a continuation-in-partapplication of U.S. patent application Ser. No. 12/014,340 filed on Jan.15, 2008, now U.S. Pat. No. 7,905,904 issued on Mar. 15, 2011, which isa continuation-in-part application of: (1.) U.S. patent application Ser.No. 11/935,681 filed on Nov. 6, 2007, now U.S. Pat. No. 7,905,903 issuedon Mar. 15, 2011, and (2.) U.S. patent application Ser. No. 11/869,440filed on Oct. 9, 2007, now U.S. Pat. No. 7,857,830 issued on Dec. 28,2010, which is a continuation-in-part of: (1.) U.S. patent applicationSer. No. 11/408,282 filed on Apr. 20, 2006 and is now abandoned, (2.)U.S. patent application Ser. No. 11/784,821 filed on Apr. 10, 2007, (3.)U.S. patent application Ser. No. 11/347,661 filed on Feb. 3, 2006 nowU.S. Pat. No. 7,749,250 issued on Jul. 6, 2010, (4.) U.S. patentapplication Ser. No. 11/347,662 filed on Feb. 3, 2006 and is nowabandoned, which is a continuation-in-part of U.S. patent applicationSer. No. 10/983,236 filed on Nov. 5, 2004 and is now abandoned.

This application is also a continuation-in-part of U.S. patentapplication Ser. No. 12/489,168 filed Jun. 22, 2009, which is acontinuation-in-part of: (1.) U.S. patent application Ser. No.12/196,405 filed on Aug. 22, 2008, now U.S. Pat. No. 8,128,658 issued onMar. 5, 2009, (2.) U.S. patent application Ser. No. 12/196,407 filed onAug. 22, 2008, now U.S. Pat. No. 8,137,382 issued on Mar. 20, 2012, and(3.) U.S. patent application Ser. No. 12/196,410, filed on Aug. 22,2008, now U.S. Pat. No. 8,118,836 issued on Feb. 21, 2012.

The disclosures of all of the above applications are hereby incorporatedby reference.

FIELD

The present teachings relate generally to soft tissue repair and, moreparticularly, to a device and associated method for repairing a tear insoft tissue.

INTRODUCTION

Tears caused by trauma or disease in soft tissue, such as cartilage,ligament, or muscle, can be repaired by suturing. Various repair deviceshave been developed for facilitating suturing and are effective fortheir intended purposes. Nevertheless, tissue repair devices forfacilitating suturing are still desirable.

SUMMARY

This section provides a general summary of the disclosure, and is not acomprehensive disclosure of its full scope or all of its features.

According to one aspect, the present teachings provide a soft tissuerepair device. The device can include a housing having a handle, adeployment system having an actuation member, and an insertion systemhaving an inserter and a slider. The slider can be coupled to theactuation member and movable relative to the inserter between deployedand retracted positions. At least a portion of a first anchor can becarried on an external surface of the slider in a first position, and atleast a portion of a second anchor can be carried on the externalsurface of the slider in a second position that is longitudinally spacedapart from the first anchor position such that the portions of the firstand second anchors are co-axial with the slider and each other. Aflexible strand can couple the first and second anchors. The insertionsystem can be operable to cooperate with the deployment system to movethe slider from the retracted position to the deployed position todeploy the first anchor upon actuating the actuation member at a firsttime, and to move the slider from the retracted position to the deployedposition to deploy the second anchor upon actuating the actuation membera second time after the first time.

According to another aspect, the present teachings provide a method forrepairing a tear in soft tissue. The method can include coupling firstand second flexible anchors with a flexible strand, providing aninsertion device having a housing with a pistol grip handle, an inserterand a slider carried in the inserter such that the inserter and theslider each have a distal end extending from the housing. The first andsecond coupled anchors can be loaded on an external surface of theslider, and the inserter can be inserted though the soft tissue from afirst side of the tear to a second side of the tear. An actuation memberprotruding from the pistol grip handle can be actuated at a first timeto translate a distal end of the slider beyond a distal end of theinserter so as to deploy the first anchor. The actuation member can bereleased after deploying the first anchor, the inserter can be insertedthrough the soft tissue for a second time in a second position, and theactuation member can be actuated at a second time after the first timeto extend the distal end of the slider beyond the distal end of theinserter and deploy the second anchor. The method can further includeremoving the inserter from the soft tissue, tensioning the flexiblestrand and reducing the tear.

Further areas of applicability will become apparent from the descriptionprovided herein. The description and specific examples in this summaryare intended for purposes of illustration only and are not intended tolimit the scope of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The present teachings will become more fully understood from thedetailed description, the appended claims and the following drawings.The drawings are for illustrative purposes only and are not intended tolimit the scope of the present disclosure.

FIG. 1 is a side view of an exemplary tissue repair device according tothe present teachings;

FIG. 2 is a top view of the exemplary tissue repair device according tothe present teachings;

FIG. 3 is a partial side view of an exemplary configuration of thetissue repair device shown with a portion of the casing removedaccording to the present teachings;

FIG. 4 is a side view of a portion of the casing of the device of FIG. 1according to the present teachings;

FIG. 5 is a side view of another portion of the casing of the device ofFIG. 1 according to the present teachings;

FIG. 6 is a partial side view of the device of FIG. 1, shown in anexemplary configuration according to the present teachings;

FIG. 7 is a partial side view of the device of FIG. 1, shown in anotherexemplary configuration according to the present teachings;

FIG. 8 is a partial side view of the device of FIG. 1, shown in anotherexemplary configuration according to the present teachings;

FIGS. 9A and 9B are perspective views of a cam member of the device ofFIG. 1 according to the present teachings;

FIG. 10 is a partial sectional view of the device of FIG. 1, shown in anexemplary configuration according to the present teachings;

FIG. 11 is an exploded perspective view of an exemplary carrying wire,positioning member, insertion member and outer cannula of the device ofFIG. 1 according to the present teachings;

FIG. 11A is a partial exploded perspective view of the carrying wire ofFIG. 11 having a pair of pre-loaded anchors according to the presentteachings;

FIG. 11B is a partial exploded perspective view of the insertion memberof FIG. 11 according to the present teachings;

FIG. 11C is a partial exploded perspective view of the outer cannula ofFIG. 11 according to the present teachings;

FIG. 12 is a perspective view of the components of FIG. 11, shown in anexemplary assembled configuration according to the present teachings;

FIGS. 13, 14, 15 and 17 are sequential views illustrating an exemplarymethod and arrangement for coupling first and second flexible anchorswith a flexible strand, and FIG. 16 shows a detail of FIG. 15 accordingto the present teachings;

FIG. 18 is a perspective view of a flexible anchor coupled with aflexible strand according to the present teachings;

FIG. 19 is a partial side view of the device of FIG. 1, shown in anexemplary configuration according to the present teachings;

FIG. 20 is a partial side view of the device of FIG. 1, shown in anotherexemplary configuration according to the present teachings;

FIG. 21 is an exemplary environmental view showing a first anchor beingdeployed outside of soft tissue according to the present teachings;

FIG. 22 is an exemplary environmental view showing first and secondanchors being deployed outside of soft tissue according to the presentteachings; and

FIG. 23 is another exemplary environmental view showing first and secondanchors being deployed outside of soft tissue according to the presentteachings.

DESCRIPTION OF VARIOUS ASPECTS

The following description is merely exemplary in nature and is in no wayintended to limit the present disclosure, its application, or uses. Forexample, although the present teachings are illustrated in anapplication for meniscus repair in knee surgery, the present teachingscan also be used for repairing any fibrous tissue, such as muscle,ligament or tendon in an arthroscopic or other open procedure, includingrotator cuff reconstruction, acromioclavicular (AC) reconstruction,anterior cruciate ligament reconstruction (ACL) and generally forfastening tendons, grafts, or strands to fibrous tissue and bone.

With initial reference to FIGS. 1-6, an exemplary tissue repair device10 according to the present teachings is illustrated. As will be furtherdescribed below, the device 10 can include a casing 20 housing a depthlimiting or positioning system 30 that cooperates with an insertionsystem 40, which can be preloaded with one or more flexible sutureanchors 50 configured to be delivered into soft tissue. Two flexiblesuture anchors 50 are illustrated in various Figures, including FIG. 6,and will be generally referred to hereinafter as first and secondflexible anchors 50 a, 50 b for clarification purposes. The casing 20can include a two-part casing having a first half portion 60 arranged toengage a second half portion 62, such that together the half portions60, 62 can form a pistol grip handle portion 64. Each casing portion 60,62 can include a proximal end 66, a distal end 68, a top 70 and a bottom72 generally located at a distal end of pistol grip handle portion 64.Casing 20 can be formed from plastic or any other suitable material.

The depth positioning system 30 can include a rotatable cam member 80,an axially moving translation member 82, a biasing member 84, and anaxially moveable outer cannula 86. With continuing reference to FIGS.1-6 and additional reference to FIGS. 7-9B, cam member 80 can include athumbwheel 90 having a first side 92, a second side 94 and an outerperiphery 96. The first side 92 can include a central first projectionor post 98 extending from a center thereof that can be positioned in acorresponding slot 100 in first casing portion 60. In a similar manner,second side 94 can likewise include a central second projection or post104 extending therefrom in an opposite direction as post 98 and can bepositioned in a corresponding slot 108 in second casing portion 62.Slots 100, 108 can have a longitudinal length greater than a diameter ofrespective posts 98, 104 so as to provide for both translation androtation of thumbwheel 90, as will be described in greater detail below.

Thumbwheel 90 can further include a toothed portion 114 disposed arounda portion of outer periphery 96 and configured to be engagable by a userof the device 10. Casing portions 60, 62 can each include respectiverecesses 118, 120 that together form an opening 122 to facilitate aportion of thumbwheel 90 extending through the opening 122 and beyond aperiphery 124 of casing 20, as shown for example in FIGS. 1 and 3. Firstside 92 can further include a first rotation limiting surface 130, afirst cam surface 132 positioned adjacent thereto, and second and thirdrotation limiting surfaces 134 and 136, respectively, the operation ofwhich will be described in greater detail below. A recess area 138 canbe formed in outer periphery 96 so as to provide access to surfaces130-136.

The toothed portion 114 can include a plurality of teeth 140 with eachtooth having an inclined or ramped surface 142 that mates with secondsurface 144 orientated generally normal to the outer periphery 96 ofthumbwheel 90. The ramped surfaces 142 can be orientated such that theyincline away from the outer periphery in a counter-clockwise directionshown by arrow A in FIG. 3.

Translation member 82 can include a longitudinally extending portion 160having a top 162, a bottom 164, a side portion 166 connecting the topand bottom 162, 164, a distal end 168 and a proximal end 170, as shownfor example in FIG. 6. Translation member 82 can be positioned in casing20 such that bottom 164 is adjacent a flange portion 174 of first casingportion 60 and top 162 is adjacent a flange portion 176 also of firstcasing portion 60, as generally shown in FIG. 4 with reference to FIG.6. Flange portions 174, 176 can form a channel that guides translationmember 82 during translation. A pair of position indication members 180,182 can extend transversely in opposite directions from top 162 so as toextend through slots 184 in respective casing portions 60, 62 as shownin FIGS. 1 and 2.

Translation member 82 can further include an L-shaped portion 188extending from distal end 168, as shown for example in FIG. 6. Aproximal end 192 of outer cannula 86 can be coupled to L-shaped portion188 such that outer cannula 86 can slidably protrude through an aperture196 formed by casing portions 60, 62. A distal end 198 of outer cannula86 can include a curved or inclined portion 200 as well as a pair ofelongated apertures 202 positioned in alignment on opposite sides ofcannula 86, as shown for example in FIG. 11C. Outer cannula 86 can alsoinclude a beveled or chamfered end 206 at a distal most end thereofadjacent to apertures 202. Chamfered end 206 can include a rounded orsmooth end for placement adjacent to or abutting tissue without piercingthe tissue. It should be appreciated that distal end 198 of outercannula 86 can also be straight or non-inclined, arcuate, angled, etc.depending on a desired use or application, and can also be provided withor without apertures 202 and chamfered end 206.

Biasing member 84 can be connected at a first end 210 to the distal end168 of translation member 82 and at a second end 212 to a tab 214 fixedto first casing portion 60. Biasing member 84 can be any suitabledevice, such as a coil spring, configured for expanding and contractingwhile also exerting a biasing force that biases the proximal end 170 oftranslation member 82 into engagement with thumbwheel 90.

With additional reference to FIGS. 10-12, the insertion system 40 willnow be described. Insertion system 40 can include a slider or carryingwire 220, an insertion member 222, a loading or positioning member 224,and a deployment system 226. Carrying wire 220 can include a solid,semi-rigid construction 230 with a proximal end 232 fixedly coupled to acam follower 234 and a distal end 236 having a suture anchor engagementportion 238. Cam follower 234 can include a generally rectangular shape242 that can be configured to translate in a track 246 defined byflanges 248 and 250 in first casing portion 60. Track 246 can furtherinclude proximal and distal ends 254 and 256 serving to limit travel ofthe cam follower 234 therebetween, as shown in FIGS. 4 and 10. A lowersurface of cam follower 234 can include a plurality of gear teeth 260configured for meshing engagement with a cam member 342 to translatecarrying wire 220 between a stowed position where cam follower 234 abutsproximal end 254 and a deployed position where cam follower 234 abutsdistal end 256, as will be further described below.

The insertion member 222 can include a tubular portion 274 extendingfrom a body member 276 at a proximal end 278 and a trough portion 280mating with the tubular portion 274 and extending therefrom to a distalend 284. The trough portion 280 can include an inclined portion 286complimentary to the inclined portion 200 of cannula 86. It should beappreciated that insertion member 222 can be provided with a straight ornon-inclined distal end that could correspond to a straight distal endof outer cannula 86. Inclined portion 286 can include depth indicatormarkers 290, as well as a pointed and chamfered distal most end 292capable of piercing skin and soft tissue. Body member 276 can beconfigured for positioning in a correspondingly shaped cavity 296 to fixinsertion member 222 relative to casing 20 and outer cannula 86. Thedistal end 284 of insertion member 222 can be received in outer cannula86 such that at least a portion of trough portion 280 and tubularportion 274 can reside within cannula 86 as shown for example in FIGS.11 and 12.

The positioning member 224 can include a tubular portion 300 fixedlycoupled to an engagement member 302 at a proximal end 304, and a distalend 306 configured to engage suture anchor 50 b, as will be described ingreater detail below in connection with the operation of device 10.Tubular portion 300 can include an inside diameter larger than thesuture engagement portion 238 of carrying wire 220 but an outsidediameter less than an inside diameter 314 of insertion member 222.Engagement member 302 can include a generally square or rectangularshape 316 configured to mate with the dimensions of track 246 such thatengagement member 302 can be slidably received within track 246. Tubularportion 300 can be slidably received within the tubular portion 274 ofinsertion member 222 such that distal end 306 and a portion of tubularportion 300 are slidably housed within insertion member 222, as shown inFIGS. 11 and 12.

Carrying wire 220 can be inserted through positioning member 224 viaaperture 320 such that positioning member 224 can translate on andrelative to carrying wire 220. With carrying wire 220 disposed throughpositioning member 224, engagement member 302 and cam follower 234 canbe positioned in track 246 such that engagement member 302 abuts adistal end 324 of cam follower 234 when cam follower 234 is in thestowed position. A retention tab 326 can also extend from a top portion328 of engagement member 302. Retention tab 326 can be configured toengage a flange 332 extending from casing portion 62 so as to retainengagement member 302 relative to flange 332 when cam follower 234 istranslated to the deployed position, as shown in FIG. 19 with referenceto FIGS. 5 and 12.

Deployment system 226 can include a trigger 340, a cam member 342 and abiasing member 344. Trigger 340 can include an aperture 348 forpivotally coupling trigger 340 to a pivot post 350 of first casingportion 60, a user engageable portion 354 and a flange member 356. Userengageable portion 354 can protrude through an aperture 360 formed byrespective casing portions 60, 62 so as to be accessible by a user, aswill be further described below. A coupling member 364 can extend froman end 366 of trigger 340 that is configured to abut cam member 342 soas to engage and couple trigger 340 to an end 368 of cam member 342.Flange member 356 can extend from aperture 348 in a directionsubstantially orthogonal to user engageable portion 354. Flange member356 can include a tab 370 protruding from a distal end thereof andconfigured to engage a corresponding tab 372 protruding from L-shapedportion 188, as shown for example in FIG. 6. When tabs 370 and 372align, trigger 340 is locked such that it can not be rotated from thenon-deployed position shown in FIG. 6.

Cam member 342 can include a generally semicircular shaped portion 380and a generally planer portion 382 spanning between respective ends 384,386 of portion 380. An aperture 390 can be centrally positioned betweenends 384, 386 and configured to engage a pivot post 392 protruding fromfirst casing portion 60 such that cam member 342 can pivot about post392. Arcuate portion 380 can include a portion 396 having a plurality ofgear teeth 398 adjacent to and configured for meshing engagement withthe plurality of gear teeth 260 of cam follower 234. Biasing member 344can be coupled at one end to a retention tab proximate arcuate portion380 and at another end to a retention post 400 protruding from firstcasing portion 60. Biasing member 344 can include a coil spring or otherdevice suitable for imparting a biasing force onto cam member 342 tobias trigger 340 to the non-deployed position, as shown for example inFIG. 6.

User engageable portion 354 of trigger 340 can be grasped by a user andsqueezed or depressed so as to rotate trigger 340 about pivot post 350.Upon such rotation, trigger end 366 can drive cam member 342 to rotateabout pivot post 392, which in turn will drivingly engage cam membergear teeth 398 with cam follower gear teeth 260 and translate camfollower 234 and carrying wire 220 forward from the stowed position tothe deployed position, as generally shown in FIG. 19. Upon the userreleasing trigger 340, the biasing force exerted by biasing member 344can return cam follower 234, cam member 342 and trigger 340 to thenon-deployed positions, as generally shown in FIGS. 6 and 20.

Returning to FIGS. 6-9B, operation of the depth positioning system 30 inconnection with the insertion system 40 and trigger lock feature willnow be described in greater detail. Thumbwheel 90 can be used to adjusta position of the outer cannula 86 relative to casing 20 and insertionmember 222. More specifically, outer cannula 86 can be axially adjustedfrom a sheathed position to several use positions such that insertionmember 222 extends at predetermined lengths relative to distal end 198of outer cannula 86.

In the sheathed position, thumbwheel 90 can be positioned such that anengagement tab 410 protruding from first casing portion 60 is positionedbetween a projecting member 412 of rotation limiting surface 134 and anedge 418 of cam surface 132, as generally shown in FIG. 9B withreference to FIG. 4. In this position, thumbwheel 90 can be preventedfrom rotating and can engage the distal end of translation member 82 atthe outer periphery 96 thereby positioning outer cannula 86 to a fullydeployed or sheathed position, as shown in FIG. 6. In the sheathedposition, outer cannula 86 can fully cover insertion member 222,carrying wire 220 and positioning member 224, as also shown in FIG. 6.

To move the depth positioning system 30 from the sheathed position to aninitial use position, a user can push thumbwheel 90 to linearlytranslate thumbwheel 90 forward towards distal end 68 such that posts98, 104 slide and translate forward in their respective slots 100, 108and projection member 412 is disengaged from tab 410. Upondisengagement, thumbwheel 90 can be rotated counter-clockwise in thedirection of arrow A such that recessed area 138 is now aligned with theproximal end 170 of translation member 82, as shown in FIG. 7. Biasingmember 84 can then urge translation member 82 rearward into recess area138 such that proximal end 170 engages first cam surface 132, asgenerally shown in FIG. 7 with additional reference to FIG. 9B. Camsurface 132 can be configured with a shape as shown that cooperates withproximal end 170 of translation member 82 and biasing member 84 to urgethumbwheel 90 to rotate in the direction of arrow A from the sheathedposition to the initial use position. In the initial use position, thedistal end 198 of outer cannula 86 can align with a first marker 414 ofdepth markers 290, and a tooth of the plurality of teeth 140 can engagea cooperating projection 422 of first casing portion 60, as also shownin FIG. 7.

In the initial use position, outer cannula 86 can be partiallytranslated rearward into casing 20 such that a distal end 284 ofinsertion member 222 is exposed. A user can now rotate thumbwheel 90 toadjust outer cannula 86 to a desired position relative to distal end 284of insertion member 222. For example, a user could adjust outer cannula86 relative to distal end 284 such that distal end 284 protrudes apredetermined distance that corresponds to a desired distance in whichinsertion member 222 can be inserted into the anatomy. In one exemplaryconfiguration, thumbwheel 90 can be used to adjust outer cannula 86relative to insertion member 222 by 8 millimeters in 2 millimeterincrements from first marker 414 to fifth marker 432, as generally shownin FIG. 8. It should be appreciated that the depth and positioningsystem 30 can be configured to provide various amounts of adjustment asmay be desired for various procedures. In this regard, thumbwheel 90 caninclude a plurality of discrete positions and/or infinite adjustmentconfigurations as may be desired for various procedures.

With continuing reference to FIGS. 6-9B and additional reference toFIGS. 1 and 11B, depth markers 290 can be used to aid a user inpositioning outer cannula 86 relative to insertion member 222. In anexemplary configuration, markers 290 and can include five discretemarkers or indicia, with the first marker 414 corresponding to adistance of 10 millimeters from the distal end 284 of insertion member222 to the distal end 198 of outer cannula 86. Each successive marker ina rearward direction towards casing 20 can be separated by 2 millimeterssuch that the fifth marker 432 can correspond to a distance of 18millimeters from distal end 284 to distal end 198.

In addition, respective sides 436 of casing 20 can also include depthindicator markings or indicia 440, as shown in FIG. 1. Markings 440 cansimilarly include five markers that correspond to the same fivepositions as the markers 290 on insertion member 222. A distal side 442of position indicator members 180, 182 can be configured to align withmarkings 440 to provide a visual indication on casing 20 of a positionof the distal end 284 of insertion member 222 relative to outer cannula86, as shown for example in FIG. 1. It should also be noted that wheninsertion system 40 is in the sheathed position, a proximal side 444 ofposition indicator members 180, 182 can align with a first marker 446 ofmarkings 440, as shown in FIG. 1.

Each tooth of the plurality of teeth 140 on thumbwheel 90 can becorrespondingly spaced apart such that thumbwheel 90 can be used toadvance or retract outer cannula 86 in the 2 millimeter incrementsdescribed above. More specifically, to retract outer cannula 86 awayfrom distal end 284 of insertion member 222, thumbwheel 90 can bepressed forward, such that teeth surfaces 144 clear cooperatingprojection 422, and then rotated in the counter-clockwise direction ofarrow A. For example, thumbwheel 90 can be translated forward andsimultaneously rotated in the direction of arrow A to retract outercannula 86 from the first marker 414 to the fifth marker 432 such thatthe distal end of insertion member 222 extends beyond outer cannula 86by a distance of 18 millimeters, as shown in FIG. 8. In this position,second surface 144 adjacent an end of tooth 434 can engage cooperatingprojection 422 and rotation limiting surface 130 can engage surface 416of first casing portion 60 adjacent engagement tab 410, as generallyshown in FIGS. 8 and 9B. On the other hand, to advance outer cannula 86towards distal end 284, thumbwheel 90 can be rotated in a directionopposite of arrow A with ramped surfaces 142 ratcheting againstcooperating projection 422 to a desired position.

With reference to FIGS. 13-18, the flexible suture anchors 50 a, 50 bwill now be described in greater detail. Each flexible anchor 50 a, 50 bcan be an elongated member having first and second ends 502, 504. Thefirst and second ends 502, 504 can be substantially perpendicular to thelongitudinal axis of the flexible anchors 50 a, 50 b. The flexibleanchors 50 a, 50 b can be made of resorbable or non-resorbablematerials, including braided suture, sponges and sponge-like materialsin solid form, perforated materials, woven/braided from biocompatiblematerials or fibers, such as, for example, polymer, polyester,polyethylene, cotton, silk, or other natural or synthetic materials,including sponges and sponge-like materials. The flexible anchors 50 a,50 b can have any properties that allow the flexible anchors 50 a, 50 bto change shape. The flexible anchors 50 a, 50 b can be, for example,compliant, flexible, foldable, squashable, squeezable, deformable, limp,flaccid, elastic, low-modulus, soft, spongy, perforated or any otherflexible member which can change shape. In some aspects, the flexibleanchors 50 a, 50 b can be coated with biological or biocompatiblecoatings, and can also be soaked in platelets and other biologics, whichcan be easily absorbed by the flexible anchors 50 a, 50 b in particularwhen, for example, the flexible anchors 50 a, 50 b are made from spongy,absorbent material.

It should be understood by the above description that the flexibleanchors 50 a, 50 b are not configured to pierce or otherwise penetratetissue either with the first and second ends 502, 504, which are bluntor with any other portion thereof. The flexible anchors 50 a, 50 b canbe loaded on the exterior of the distal end 256 of carrying wire 220, aswill be discussed in greater detail below. The flexible anchors 50 a, 50b can be in the form of an elongate flexible tube defining a bore 508along their length, as shown in FIG. 18.

The first and second flexible suture anchors 50 a, 50 b can be coupledtogether with a flexible suture or strand 512. The flexible strand 512can have first and second ends 514, 516 and can be made of braidedfilaments or fibers of biocompatible material, including natural andsynthetic fibers, such as cotton, silk, polymer, polyester,polyethylene, thin wire, suture, and other materials. The flexiblestrand 512 can be braided in a tubular or hollow form such that it formsan internal passage 520 between the first and second ends 514, 516.

A small knot or other retaining device 518 can be optionally formedadjacent the first end 514. The flexible strand 512 can be passedthrough a first opening 528 of each of the flexible anchors 50 a, 50 b,guided along the corresponding bore 508 and passed through a secondopening 530 of each flexible anchor 50 a, 50 b, as for example shown inFIG. 18. The openings 528, 530 can be positioned intermediately betweenthe first and second ends 502, 504 of each flexible anchor 50 a, 50 b ata distance of, for example, one-quarter length from the ends 502, 504 ofeach flexible anchor 50 a, 50 b. Furthermore, it will be appreciatedthat the openings 528, 530 can be apertures or voids in the woven fabricof the flexible anchors 50 a, 50 b, such that the openings 528, 530 donot disrupt or break the weave of flexible anchors 50 a, 50 b, when theflexible anchor 50 a, 50 b are made of braided or woven material.

After the flexible anchors 50 a, 50 b are mounted on the flexible strand512, the second end 516 of the flexible strand 512 can be inserted intothe internal passage 520 of the flexible strand 512 at an aperture 534,guided longitudinally along the passage 520, and led out of the passage520 of the flexible strand 512 at an aperture 538. The portion of thestrand 512 between apertures 534 and 538 can form an adjustment portion542 between the optional knot 518 and the opening 528 of the secondflexible anchor 50 b, such that the flexible strand 512 defines a singleadjustable knotless loop 546, as shown in FIGS. 15 and 16. The secondflexible anchor 50 b can be slidably moved along the flexible strand 512until the adjustment portion 542 is within the bore 508 of the secondflexible anchor 50 b and the knot 518 is adjacent the opening 528 of thesecond flexible anchor 50 b, as shown in FIG. 17. It will beappreciated, however, that the adjustment portion 542 can remain in theposition shown in FIG. 15 outside of bore 508. The adjustable knotlessloop 546 is self-locking and does not require the surgeon to tie a knotduring a surgical procedure for securing the flexible strand 512.Further, once the adjustable knotless loop 546 is self-locked by pullingthe second end 516 of the flexible strand 512 and tensioning theflexible strand 512, friction prevents the adjustable knotless loop 546from being loosened, thereby providing a secure lock. Additional detailsregarding forming the knotless adjustable loop 546, and additionaladjustable knotless loop configurations are disclosed in co-pending andcommonly assigned U.S. patent application Ser. No. 11/541506, filed onSep. 29, 2006, the disclosure of which is incorporated herein byreference.

For discussion purposes, the anchors 50 a, 50 b, together with flexiblestrand 512 configured in the knotless loop 546 can be hereinafterreferred to as the anchor system 550. With reference to FIGS. 6 and 11A,the anchor system 550 can be pre-loaded in an in-line configuration onthe carrying wire 220 such that anchor 50 a is positioned beforeflexible anchor engagement portion 238 and second anchor 50 b ispositioned after engagement portion 238. In the in-line configuration,carrying wire 220 can extend through a portion of bore 508 of anchors 50a, 50 b and then pierce though each anchor thereby creating a tailportion 548 that is not coaxial with carrying wire 220, as shown forexample in FIG. 11A. In this configuration, the anchors 50 a, 50 b canreside in the trough portion 280 of insertion member 222. The flexiblestrand 512 can be packaged within outer cannula 86 along side insertionmember 222 and positioning member 224. Second end 516 of flexible strand512 can extend out of outer cannula 86 through aperture 196 and into atubular housing member 560 positioned in a handle portion of firstcasing portion 60, as shown for example in FIG. 6.

Returning to FIGS. 11 and 11A, the suture anchor engagement portion 238of carrying wire 220 will now be described in greater detail. Sutureengagement portion can have a flattened area 580 having a thickness lessthan the outside diameter 312 of carrying wire 220. Flattened area 580can be formed so as to maintain the same cross-sectional area as a crosssection through a non-flattened portion of carrying wire 220, therebyproviding for the suture anchors 50 a, 50 b to be sized relative to thediameter of carrying wire 220 while ensuring that they can slide overthe engagement portion 238, as will be further described below.

The engagement portion 238 can further include a one-way barb 584configured such that flexible anchors 50 a, 50 b can slide or travelover barb 584 in only one direction of travel from the proximal end 254of carrying wire 220 to the distal end 236 thereof. One-way barb 584 canbe defined by a recess or cut-out 588 formed in the flattened sectionsuch that a distal end 590 of an open end of recess 588 mates with aportion of flattened area 580 having a first width 592. A proximal end594 of the recess 588 also adjacent the opening can mate with anotherportion of the flattened area 580 having a second width 598 greater thanthe first width 592. Flattened area 580 can also include curvedtransition areas 597, 599 between the flattened area 580 and anon-flattened area of the carrying wire on a proximal side thereof, asshown in FIG. 11A.

In use, the larger second width 598 of flattened area 580 and the anglednature of one-way barb 584 provides for suture anchor 50 b to be able toslide or travel over the barb 584 in a proximal to distal directionwithout being caught or stopped by barb 584. In a similar manner,carrying wire 220 can slide or travel relative to suture anchor 50 b ina distal to proximal direction without barb 584 catching or stoppingflexible anchor 50 b. Conversely, the smaller first width 592 offlattened area 580 in cooperation with barb 584 provides for catching aninterior surface of bore 508 of suture anchor 50 b when carrying wire220 moves in a proximal to distal direction relative to flexible anchor50 b.

Referring now to FIGS. 6-8 and 19-23, the soft tissue repair device 10pre-loaded with suture anchors 50 a, 50 b can be used to repair a softtissue defect 600, such as, for example, a tear, or other weakness infibrous soft tissue 602, such as in meniscal tissue, cartilage, muscleor other fibrous tissue under the skin. An outer incision 601 can bemade through the skin to access the soft tissue 602 and a user caninsert the distal end 198 of outer cannula 86 to the surgical site. Anappropriate insertion depth can be determined for the insertion member222 and the user can translate and rotate thumbwheel 90, as discussedabove, to unlock the depth and positioning system 30 from the sheathedposition to the initial use position. The outer cannula 86 can then beadjusted relative to insertion member 222 such that distal end 284extends beyond outer cannula 86 a distance corresponding to the desiredinsertion depth.

The exposed distal end 284 of insertion member 222 can be insertedthrough first entry point 604 into soft tissue 602 from a first side ofthe defect 600 until the distal end 284 can exit a second side 606 ofthe fibrous soft tissue 602, such as an outer surface or back side of ameniscus of a knee joint or other outer surface of a fibrous tissue. Inthis position, the distal end 198 of outer cannula 86 can be adjacent toor abutting the first entry point 604. It should be appreciated that thechamfered end 292 of insertion member 222 could alternatively be used topierce the skin without requiring an incision 604.

With distal end 284 of insertion member 222 appropriately positioned,the trigger 340 can be squeezed or depressed to translate carrying wire220 forward relative to insertion member 222 such that one-way barb 584engages first flexible suture anchor 50 a and delivers anchor 50 a onthe second side 606 of the soft tissue 602 at a first location, as shownin FIGS. 19 and 21. It should be appreciated that the manner andstructure of the pre-assembled anchor system 550 in-line on carryingwire 220 allows the anchor 50 a to pass through a narrow opening orslit, first entry point 604, formed in the tissue 602 by the chamferedend 292 of insertion member 222. It should also be appreciated that theU-shaped trough portion 280 of insertion member 222 requires a smallerinsertion area than a fully enclosed, circular shaped insertion memberwould require and will not core a plug of tissue.

As cam follower 234 translates carrying wire 220 forward to deploy firstanchor 50 a in connection with depressing trigger 340, cam follower 234also simultaneously translates positioning member 224 forward such thatdistal end 306 engages second flexible anchor 50 b and moves anchor 50 bforward towards distal end 198 of outer cannula 86, as shown in FIGS. 19and 20. Tubular portion 300 of positioning member 224 can have a lengthsuch that when trigger 340 is fully depressed to deploy first anchor 50a, second anchor 50 b will be carried forward to a position adjacentapertures 196 and distal end 198 of outer cannula 86. In this position,retention tab 326 can engage flange 332 to retain positioning member 224and thus anchor 50 b in this advanced position when trigger 340 isreleased. After the first anchor 50 a has been deployed, the trigger 340can be released thereby retracting the distal end 284 of insertionmember 222 such that one-way barb 584 is positioned rearward of orwithin bore 508 of suture anchor 50 b, as generally shown in FIGS. 19and 21. When insertion member 222 is retracting, the tail portion 548 ofsuture anchor 50 a can engage the soft tissue side 606 such that it willbe removed from insertion member 222 as insertion member 220 retracts tothe stowed position.

With the first anchor 50 a deployed, the insertion device 10 can beremoved from the soft tissue 602 while portions 610 of the knotless loop546 can slide out from insertion device 10 as flexible anchor isretained in soft tissue 602. Insertion device 10 can then be inserted ata second location or entry point 605 on a second side of the soft tissuedefect 600, as shown in FIG. 22. Once distal end 284 of insertion member222 is appropriately positioned, such as beyond second side 606, trigger340 can again be squeezed or depressed to deploy second anchor 50 badjacent to first anchor 50 a. Depressing trigger 340 again translatescarrying wire 220 forward such that one-way barb 584 engages an interiorof bore 508 and deploys second flexible anchor 50 b at the secondlocation such that tail portion 548 of anchor 50 b can engage softtissue side 606 upon retraction on insertion member 222, as alsogenerally shown in FIG. 22. Insertion device 10 can then be removed fromthe soft tissue 602 and the skin incision 601 with the second end 516 ofthe flexible strand 512 being removed from the soft tissue 602 alongwith insertion device 10, as also shown in FIG. 22. Once second anchor50 b is implanted and insertion device 10 removed from the soft tissue602, any remaining portion of second flexible strand end 516 not removedfrom outer cannula 86 and housing member 560 can be subsequentlyremoved.

Pulling the second, free end 516 of the flexible strand 512 can tightenthe adjustable knotless loop 546, secure the first and second flexibleanchors 50 a, 50 b against the second side surface 606 of the softtissue 602, and reduce the defect 600. Further, portions 614 of theanchors 50 a, 50 b between the first and second ends 502, 504 and thecorresponding first and second openings 528, 530, can define anchoringleg portions 614 that can provide additional resistance for securing theflexible anchors 50 a, 50 b on the surface 606 of the soft tissue 602,as these leg portions can be forced against surface 606 for anchoring,as shown for example in FIG. 23.

It will be appreciated from the above description and drawings that thepresent teachings provide flexible anchors that can be passed throughtissue easily in a compact or low profile configuration and ororientation and then positioned outside tissue in a second orientationthat provides anchoring without tissue penetration, preventingwithdrawal from the tissue and reducing tissue injury. Further, the useof an inserter provided with preassembled anchors can help reduce thetime length of the procedure and simplify manipulations required duringthe procedure.

It will be further understood that the various aspects of the depthpositioning system, insertion system, deployment system and anchors canbe mixed and matched or combined in ways other than those explicitlydiscussed above, without departing from the scope of the presentteachings.

The foregoing discussion discloses and describes merely exemplaryarrangements of the present disclosure. One skilled in the art willreadily recognize from such discussion, and from the accompanyingdrawings and claims, that various changes, modifications and variationscan be made therein without departing from the spirit and scope of thepresent teachings as defined in the following claims.

1. A method for repairing a tear in soft tissue, comprising: couplingfirst and second flexible anchors with a flexible strand; providing aninsertion device having a housing with a pistol grip handle, an inserterand a slider carried in the inserter, wherein the inserter and theslider each have a distal end extending from the housing; loading thefirst and second coupled anchors on an external surface of the slider;inserting the inserter through the soft tissue at a first position froma first side of the tear to a second side of the tear; actuating anactuation member protruding from the pistol grip handle at a first timeto translate a distal end of the slider beyond a distal end of theinserter; deploying the first anchor; releasing the actuation memberafter deploying the first anchor; inserting the inserter through thesoft tissue for a second time in a second position; actuating theactuation member a second time after the first time to extend the distalend of the slider beyond the distal end of the inserter and deploy thesecond anchor; removing the inserter from the soft tissue; tensioningthe flexible strand; and reducing the tear.
 2. The method of claim 1,wherein coupling first and second anchors includes forming an adjustableknotless loop with the flexible strand, the loop passing through aportion of each flexible anchor; and wherein loading the first andsecond flexible anchors includes positioning an internal longitudinalbore of the first and second flexible anchors coupled with theadjustable knotless loop over the external surface of the slider suchthat at least a portion of the first and second anchors are coaxial withthe slider and each other.
 3. The method of claim 2, wherein forming anadjustable knotless loop includes passing a first end of the flexiblestrand through a longitudinal passage defined by a portion of theflexible strand.
 4. The method of claim 2, further comprisingpositioning the first and second anchors on the slider such that thefirst anchor is on a distal side of an engagement portion of the slider,and the second anchor is on a proximal side of the engagement portion.5. The method of claim 1, wherein providing an insertion device furtherincludes providing an insertion device with an outer cannula having adistal end extending from the housing and a proximal end coupled to anadjustment mechanism, the slider and the inserter being positioned in alongitudinal passage extending through the outer cannula.
 6. The methodof claim 5, further comprising adjusting a distal end of the outercannula relative to the distal end of the inserter such that the distalend of the inserter extends beyond the distal end of the outer cannulaso as to establish an insertion depth of the inserter; and whereininserting the inserter through the soft tissue includes inserting theextending distal end of the inserter through the soft tissue until thedistal end of the outer cannula abuts an exterior surface of the softtissue.
 7. The method of claim 1, wherein depressing an actuation memberfurther includes translating a positioning member disposed coaxiallyaround the slider and inside the inserter to translate the second anchorforward towards the distal end of the inserter.
 8. The method of claim7, wherein releasing the actuation member further includes retractingthe slider to a retracted position such that an engagement portion ofthe slider is positioned adjacent to or beyond the translated secondanchor; and wherein depressing the actuation member a second timeincludes depressing the actuation member a second time after releasingthe actuation member and translating the second anchor to the thirdposition such that the engagement portion of the slider engages thesecond anchor and moves the second anchor beyond the distal end of theinserter.
 9. The method of claim 1, wherein tensioning the flexiblestrand includes self-locking the adjustable loop.
 10. The method ofclaim 9, wherein loading the first and second flexible anchors includesloading the first and second flexible anchors in a substantially linearfirst shape on an external surface of the slider; and wherein tensioningthe flexible strand further includes changing the shape of each flexibleanchor from the first shape to a second deformed shape that is suitablefor securely lodging each flexible anchor relative to the soft tissue.11. The method of claim 2, wherein loading the first and second coupledanchors further includes positioning only a portion of the internalbores of the first and second coupled anchors over the external surfaceof the slider such that a first portion of each anchor is coaxial withthe slider and a second tail portion of each anchor extends at an anglerelative to the slider, and wherein the second tail portion isconfigured to engage the soft tissue when the actuation member isreleased and the slider is retracted from being translated beyond thedistal end of the inserter.
 12. A method for repairing a tear in softtissue, comprising: adjusting a position of a distal end of an outercannula relative to a distal end of an inserter; inserting the distalend of the inserter into soft tissue at a first position where thedistal end of the outer cannula engages the soft tissue so as toestablish an insertion depth of the inserter; actuating an actuationmember at a first time to translate a distal end of a slider locatedwithin the inserter and carrying a first anchor beyond a distal end ofthe inserter; deploying the first anchor relative to the soft tissue;and removing the inserter from the soft tissue.
 13. The method of claim12, further comprising: releasing the actuation member after deployingthe first anchor; retracting the slider to a retracted position suchthat an engagement portion of the slider is positioned adjacent to atranslated second anchor; and actuating the actuation member at a secondtime to deploy the second anchor upon the engagement portion of theslider engaging the second anchor and moving the second anchor beyondthe distal end of the inserter.
 14. The method of claim 13, furthercomprising tensioning a flexible strand coupled to the first and secondanchors to close the tear in the soft tissue.
 15. The method of claim13, wherein actuating the actuator at a first time includes translatinga positioning member disposed coaxially around the slider and inside theinserter to translate the second anchor forward toward the distal end ofthe inserter.
 16. The method of claim 12, wherein only a portion of aninternal bore of the first anchor is positioned over an external surfaceof the slider such that a first portion of the first anchor is coaxialwith the slider and a second tail portion extends at an angle relativeto the slider.
 17. A method for repairing a tear in soft tissue,comprising: inserting a distal end of an inserter into the soft tissueat a first position; actuating an actuation member of a pistol griphandle at a first time to translate a distal end of a slider locatedwithin the inserter and carrying a first anchor and a second anchorbeyond the distal end of the inserter; deploying the first anchor;releasing the actuation member after deploying the first anchor;inserting the distal end of the inserter into the soft tissue at asecond position; actuating the actuation member at a second time toextend the distal end of the slider beyond the distal end of theinserter; deploying the second anchor; and removing the inserter fromthe soft tissue.
 18. The method of claim 17, further comprising:tensioning a flexible strand coupled to the first anchor and the secondanchor; changing a configuration of the first anchor and the secondanchor from a first configuration to a second configuration upontensioning; and reducing the tear.
 19. The method of claim 17, whereinactuating an actuation member further includes translating a positioningmember disposed coaxially around the slider and inside the inserter totranslate the second anchor forward towards the distal end of theinserter.
 20. The method of claim 17, wherein releasing the actuationmember further includes retracting the slider to a retracted positionsuch that an engagement portion of the slider is positioned adjacent toor beyond the translated second anchor; and wherein depressing theactuation member a second time includes depressing the actuation membera second time after releasing the actuation member and translating thesecond anchor such that the engagement portion of the slider engages thesecond anchor and moves the second anchor beyond the distal end of theinserter.